pharmacovigilance working party (phvwp)
De Pharmacovigilance Working Party (PhVWP)
brengt advies uit over de risico's van geneesmiddelen na
toelating op de Europese markt. Dit advies betreft onder meer de
evaluatie van mogelijke bijwerkingen en de risico's van
geneesmiddelen. In deze CHMP-werkgroep op het gebied van
farmacovigilantie wordt het CBG vertegenwoordigd door Sabine
Straus (Hoofd Afdeling Farmacovigilantie). Eugène van
Puijenbroek is benoemd als onafhankelijk deskundige (co-opted
member) van de PhVWP en werkt als Hoofd van de Afdeling Analyse
bij het Nederlands Bijwerkingen Centum Lareb.
De PhVWP publiceert
maandelijks een verslag over de belangrijkste adviezen en
aandachtspunten van de vergadering.
De berichten bevatten:
- informatie over producten die niet via de centrale procedure
zijn geregistreerd
- adviezen aan registratieautoriteiten in de lidstaten op het
gebied van de werkzaamheid en de risico’s van geneesmiddelen
- informatie over discussies met betrekking tot de risico’s van
een bepaald geneesmiddel
- definitieve richtlijnen op het gebied van
geneesmiddelenbewaking
- concept richtlijnen en dergelijke op het gebied van
geneesmiddelenbewaking die openstaan ter consultatie;
- onderwerpen waar de PhVWP bijdraagt aan openbare bijeenkomsten
of consultaties
- algemene onderwerpen over de organisatie van het Europese
registratienetwerk
January 2012
Monthly Report - Pharmacovigilance Working Party
(PhVWP) januari 2012 plenary meeting
Besproken onderwerpen:
Safety concerns
- Ethinylestradiol + drospirenone-containing oral contraceptives
(Yasmin, Yasminelle and other products) – Risk of venous
thromboembolism
***
December 2011
Monthly Report - Pharmacovigilance Working Party
(PhVWP) december 2011 plenary meeting
Besproken onderwerpen:
Safety concerns
- Gonatropin-releasing hormone (GnRH) agonists – Risk of
depression
- HMG-CoA reductase inhibitors – Risk of new onset diabetes
- Methotrexate – Risk of overdose due to erroneous daily intake
of the weekly dose in rheumatologic and dermatologic
indications
- Montelukast – Risk of psychiatric adverse reactions in
children
- Proton-pump inhibitors – Risk of hypomagnesaemia with long-term
use
Guidelines and general matters
- Work Plan for the CHMP Pharmacovigilance Working Party
2012
- CHMP Guideline on Immunogenicity Assessment of Monoclonal
Antibodies Intended for In-vivo Clinical Use
***
November 2011
Monthly Report - Pharmacovigilance Working Party
(PhVWP) november 2011 plenary meeting
Besproken onderwerpen:
Safety concerns
- Atomoxetine – Updated information on effects on blood pressure
and heart rate
- Escitalopram – Risk of QT interval prolongation
- Rosuvastatin - Risk of gynaecomastia
- Tibolone – Risk of venous thromboembolism, myocardial
infarction, breast cancer and ovarian cancer
- Topiramate – Updated information on risk of congenital
malformations
***
Oktober 2011
Monthly Report - Pharmacovigilance Working Party
(PhVWP) oktober 2011 plenary meeting
Besproken onderwerpen:
Safety concerns
- Antiepileptics – Risk of bone disorder
- Citalopram – Risk of QT interval prolongation
- Domperidone - Risk of cardiac disorders
Guidelines and general matters
- ICH Implementation Guide (ICH-E2B(R3)) for the International
Standard for the Electronic Transmission of Individual Case Safety
Reports
***
September 2011
Monthly Report - Pharmacovigilance Working Party
(PhVWP) september 2011 plenary meeting
Besproken onderwerpen:
Safety concerns
Active substances with a known risk of Stevens-Johnson syndrome
and toxic epidermal necrolysis (allopurinol, carbamazepine,
lamotrigine, phenobarbital, phenytoin, meloxicam, piroxicam,
tenoxicam, nevirapine, sulfadiazine, sulfadoxine, sulfafurazole,
sulfamethoxazol and sulfasalazine)
***
Juli 2011
Monthly Report - Pharmacovigilance Working Party
(PhVWP) July 2011 plenary meeting
Besproken onderwerpen:
Safety concerns
- Antipsychotics - Risk of extrapyramidal effects and withdrawal
symptoms in newborns after exposure during pregnancy
- Fusidic acid - Risk of rhabdomyolysis due to interaction with
HMG-CoA reductase inhibitors
- Plantago ovata (syn.: P.isphagula) - Risk of allergic reactions
after prolonged occupational exposure
- Reboxetine - Confirmation of positive benefit-risk
balance
Guidelines and general matters
***
Juni 2011
Monthly Report - Pharmacovigilance Working Party
(PhVWP) June 2011 plenary meeting
Besproken onderwerpen:
Safety concerns
- Beta-blockers for ophthalmic use – Risk of systemic adverse
reactions.
- GEMCITABINE ACTAVIS – Risk of adverse reactions due to
increased alcohol concentration after reconstitution error.
- Hydrochlorothiazide – Use during breast-feeding.
- Testosterone 10% for topical use – Risk of virilisation in
children after exposure through interpersonal skin
contact.
Guidelines and general matters
- Meetings of the International Conference on Harmonisation of
Technical Requirements for Registration of Pharmaceuticals for
Human Use (ICH) in June 2011.
- Guide on the interpretation of spontaneous case reports of
suspected adverse reactions to medicines.
- Study of influential stakeholders’ expectations and attitudes
regarding benefit-risk communication by the European Medicines
Agency.
- Driving under the Influence of Drugs, Alcohol and Medicines -
The Integrated Project DRUID under the European Commission’s 6th
Framework Programme.
***
Mei 2011
Monthly Report - Pharmacovigilance Working Party
(PhVWP) May 2011 plenary meeting
Besproken onderwerpen:
Safety concerns
- Ethinylestradiol + drospirenone-containing oral contraceptives
(YASMIN, YASMINELLE and other products) – Risk of venous
thromboembolism.
- Yttrium citrate (90Y) – Risk of osteonecrosis with injection
for inflammatory rheumatism of the knee.
Guidelines and general matters
- New term of PhVWP Patient Observers.
***
April 2011
Monthly Report -
Pharmacovigilance Working Party (PhVWP) April 2011 plenary
meeting
Besproken onderwerpen:
Safety concerns
- Bricanyl Turbohaler (terbutaline) - Effect of physical impact
on accuracy of dose delivery and recommended 100 dose pack
size.
- Isotretinoin – Risk of psychiatric reactions.
***
Maart 2011
Monthly Report - Pharmacovigilance Working Party
(PhVWP) March 2011 plenary meeting
Besproken onderwerpen:
Safety concerns
- High-ceiling diuretics - Evidence does not confirm risk of
basal cell.
***
Februari 2011
Monthly Report - Pharmacovigilance Working Party
(PhVWP) Februari 2011 plenary meeting
Besproken onderwerpen:
Safety concerns
- Montelukast – Reports of psychiatric and behaviour-related
adverse reactions.
- Paracetamol – Available evidence does not support a causal
relationship between paracetamol and asthma in children after
exposure in pregnancy or use in early infancy.
Guidelines and general matters
- European Medicines Agency’s Transatlantic Workshop on
Drug-Related Progressive Multifocal Leukoencephalopathy.
***
Januari 2011
Monthly Report - Pharmacovigilance Working Party
(PhVWP) Januari 2011 plenary meeting
Besproken onderwerpen:
Safety concerns
- Insulin products – Consistent product information regarding the
risk of heart failure with concomitant use of
pioglitazone.
Guidelines and general matters
- New legislation for pharmacovigilance in the European
Union.
***
December 2010
Monthly Report - Pharmacovigilance Working Party
(PhVWP) December 2010 plenary meeting
besproken onderwerpen:
Safety concerns
- Fluoroquinolones – Risk of QT interval prolongation.
Guidelines and general matters
- Work plan for the CHMP Pharmacovigilance Working Party
2011.
- Meetings of the International Conference on Harmonisation of
Technical Requirements for Registration of Pharmaceuticals for
Human Use (ICH) in November 2010.
***
November 2010
Monthly Report - Pharmacovigilance Working Party
(PhVWP) November 2010 plenary meeting
besproken onderwerpen:
Safety concerns
- Corticosteroids for inhalational or intranasal use – Risk of
psychiatric, behavioural and other systemic adverse
reactions.
Guidelines and general matters
- European Network of Centres for Pharmacoepidemiology and
Pharmacovigilance (ENCePP).
- Research on Direct Healthcare Professional Communications
(DHPCs) in the Netherlands.
***
Oktober 2010
Monthly Report - Pharmacovigilance Working Party
(PhVWP) October 2010 plenary meeting
besproken onderwerpen:
Safety concerns
- Adrenaline-containing auto-injectors EPIPEN/ALTELLUS – Risk of
failure of self-injection due to labelling
- Bisphosphonates for oral use – Risk of oesophageal irritation
but insufficient evidence to conclude a causal relationship with
oesophageal cancer
- Long-acting beta2-adrenoceptor agonist bronchodilators
formoterol and salmeterol – Review of safety in the management of
asthma
***
September 2010
Monthly Report - Pharmacovigilance Working Party
(PhVWP) September 2010 plenary meeting
besproken onderwerpen:
Safety concerns
- Benzydamine – Risk of adverse reactions after incorrect oral
intake
- Lamotrigine – Risk of aseptic meningitis
- Tamoxifen – Risk of reduced therapeutic response in patients
who are poor CYP2D6 metabolisers or use medicines inhibiting
CYP2D6
Guidelines and general matters
- Election of PhVWP Vice-Chairperson
- New legislation for pharmacovigilance in the European
Union
- 1st EMA Scientific Workshop on Nanomedicines on 2-3 September
2010
***
Juli 2010
Monthly Report - Pharmacovigilance Working Party
(PhVWP) July 2010 plenary meeting
besproken onderwerpen:
PhVWP discussions on safety concerns
- Camphor for external or inhaled use – Risk of toxic effects
after accidental oral intake
- Isotretinoin for oral use – Risk of erythema multiforme,
Stevens Johnson syndrome and toxic epidermal necrolysis
Guidelines and general matters
- Medical Dictionary for Drug Regulatory Activities (MedDRA) –
List of Important Medical Event Terms (IME)
- European Programme in Pharmacovigilance and
Pharmacoepidemiology (Eu2P)
***
Juni 2010
Monthly Report - Pharmacovigilance Working Party
(PhVWP) June 2010 plenary meeting
besproken onderwerpen:
PhVWP discussions on safety concerns
- Cisplatin – Risk of increased ototoxicity in patients with
genetic variants of TMPT and COMT
Guidelines and general matters
- CMD(h) & PhVWP Best Practice Guide on Communication and
Implementation of Safety Information
***
Mei 2010
Monthly Report - Pharmacovigilance Working Party
(PhVWP) May 2010 plenary meeting
besproken onderwerpen:
PhVWP discussions on safety concerns
- Low-molecular-weight iron dextran – Risk of allergic
reactions
- Rosuvastatin – Risk of diabetes
***
April 2010
Monthly Report - Pharmacovigilance Working Party
(PhVWP) April 2010 plenary meeting
besproken onderwerpen:
PhVWP discussions on safety concerns
- Dipyridamole in combination with acetylsalicylic acid – No
evidence for increased risk of ischaemic stroke versus
acetylsalicylic acid alone in the European population
- Latanoprost – No evidence for risk of malignant melanomas of
the eye and skin
***
Maart 2010
Monthly Report - Pharmacovigilance Working Party
(PhVWP) March 2010 plenary meeting
besproken onderwerpen:
PhVWP discussions on safety concerns
- Antidepressants – Risk of bone fractures
- Isotretinoin for oral use – Risk of erythema multiforme
- Lamotrigine – No evidence of increased risk of fatal liver
failure
- Omeprazole and esomeprazole – Risk of reduced plasma levels of
clopidogrel due to interaction
- PERFALGAN (paracetamol) 10 mg/ml solution for infusion – Risk
of dosing errors in infants resulting in overdose with serious
outcome
- Serotonergic antidepressants – Risk of persistent pulmonary
hypertension of the newborn
- YASMIN/YIRA (ethinylestradiol 30μg + drospirenone) – Risk of
venous thromboembolism
Guidelines and general matters
- CHMP Guideline on Duplicate Detection and Management of
Individual Cases and Individual Case Safety Reports
***
Februari 2010
Monthly Report - Pharmacovigilance Working Party
(PhVWP) February 2010 plenary meeting
besproken onderwerpen:
PhVWP discussions on safety concerns
- Fluoxetine – Risk of cardiovascular birth defects
Guidelines and general matters
- Pharmacovigilance for medicinal products used against novel
Influenza A (H1N1) virus
- Appointment of three new Co-opted PhVWP Members
***
Januari 2010
Monthly Report - Pharmacovigilance Working Party
(PhVWP) January 2010 plenary meeting
besproken onderwerpen:
PhVWP discussions on safety concerns
- Hormone Replacement Therapy containing oestrogen with and
without progesterone – 3rd revision of Core Summary of Product
Characteristics
- Salmon calcitonin – No association with progression of prostate
cancer
- Valproic acid – Interaction with carbapenems
Guidelines and general matters
- Pharmacovigilance for medicinal products used against novel
Influenza A (H1N1) virus